MAUDE Adverse Event Report: HOLGER ULLRICH HYBRID OR TABLE COLUMN, SURFACE-MOUNTED; TABLE, OPERATING-ROOM, AC-POWERED

Model Number 118001B1

Device Problems Mechanical Problem (1384); Unintended Movement (3026)

Patient Problems Head Injury (1879); Injury (2348)

Event Date 06/24/2019

Event Type  Injury  

Event Description

The following was reported.A patient fell to the ground during transfer from a stretcher to the table.According to the customer this happened, because the or table rotated.The or table can be rotated.The rotation movement can be locked by pushing a locking lever down four times.The customer stated that the column was locked and the firm seat of the column was checked.The affected table column was investigated by a member of getinge.The described issue (movement of the column when the rotation movement was locked) could not be reproduced.No damage at the locking mechanism was apparent.The patient suffered injuries at the head and clavicle.Manufacturer reference # (b)(4).

Manufacturer Narrative

A getinge-maquet field service engineer has investigated the affected device.The described malfunction could not be reproduced and no other failure was found.The user stated that the firm seat of the column was checked after it was locked.Since no malfunction was found during the investigation and the firm seat was checked according to the user, we assume that the brake was released unintentionally.We assume that the locking lever of the brake was lifted upwards to release the brake by mistake.In the instruction for use (ifu) the user is warned as follows concerning the risks related to the possibility to rotate this column: "warning! risk of injury! the stationary column may rotate if the column is not locked.Before every operation / examination ensure that the stationary column is locked." we got the information from the customer that the patient is doing well, no medical intervention was required.Getinge-maquet gmbh provides product failure investigation, analysis and resolution for the device described in this report.

Event Description

Manufacturer reference # (b)(4).

• Brand Name: HYBRID OR TABLE COLUMN, SURFACE-MOUNTED
• Type of Device: TABLE, OPERATING-ROOM, AC-POWERED
• Manufacturer (Section D): HOLGER ULLRICH; maquet gmbh; kehler strasse 31,; rastatt 76437 ; GM 76437
• MDR Report Key: 8776174
• MDR Text Key: 150567596
• Report Number: 3013876692-2019-00009
• Device Sequence Number: 1
• Product Code: FQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 118001B1
• Device Catalogue Number: 118001B1
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/18/2019
• Distributor Facility Aware Date: 12/18/2019
• Date Report to Manufacturer: 12/18/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/10/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 90